MAUDE Adverse Event Report: SYNTHES GMBH 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.016.240S

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the multiloc peg was introduced with the applicator in an attempt to lock, but the locking holes were found to be misaligned.The surgeon removed the nail and observed that it was damaged at the zone of the tip connection of insertion handle.The implant was changed for a new one.Procedure was completed successfully with a delay of ten minutes.There was no patient consequence.This report is for a 7mm titanium (ti) multiloc humeral nail.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: a dhr review could not be performed as the device lot number is unknown.Photo investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, no damages to the multi-loc holes could be identified.The thread insert and the inlay of the nail head were not visible from the images provided.However, the proximal head end of the nail appears to have deformed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection was not completed.Document/specification review: the following drawings (current) were reviewed- multiloc hn right ø7,ø8.5 asm, multiloc humeral nail right ø7,ø8.5, thread insert for phn/hn, inlay for phn/hn right.No design issues or discrepancies were found during this investigation.Conclusion: the overall complaint can be confirmed during photo investigation as the proximal head end of the nail appears to have deformed.The root cause for the reported event cannot be determined from the available information.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection: the multiloc hn ø7 r cann l240 tan (p/n: 04.016.240s, lot number: 52p5531) was received at us cq.Upon inspecting the device, no damages to the multi-loc holes could be identified.The inlay of the nail head was deformed and the proximal head end of the nail also has deformed.However, no broken components were identified.Reported condition of broken could not be confirmed.Functional test: a functional assessment could not be performed.However the deformed inlay and the deformed head could have caused the complaint condition.Device failure/defect identified? yes.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the functional complaint condition could have been caused due to the deformed head and inlay components of the nail.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot product code: 04.016.240s, lot number: 52p5531, manufacturing site: mezzovico, release to warehouse date: 29 july 2020, expiry date: 01 july 2025.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history review a dhr review could not be performed as the device lot number is unknown.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: updated data: d4, h4.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Corrected data: d4, d9, h3, h6.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6- the overall complaint can be confirmed during photo investigation as the proximal head end of the nail appears to have deformed.The root cause for the reported event cannot be determined from the available information.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.A dhr review could not be performed as the device lot number is unknown.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12481010
• MDR Text Key: 271681020
• Report Number: 8030965-2021-07782
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819426146
• UDI-Public: (01)07611819426146
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.016.240S
• Device Lot Number: 52P5531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 10/13/2021; 11/23/2021; 12/02/2021; 12/02/2021
• Supplement Dates FDA Received: 10/15/2021; 11/30/2021; 12/02/2021; 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male