MAUDE Adverse Event Report: SYNTHES GMBH 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/270MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.019.270S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, that support is provided for placement of a multilock nail in the left upper limb.During the procedure, it was determined that the measurement corresponds to a nail 8.5 x 270.When placed, it showed signs of loosening in the frame and connection screw.When trying to lock, it was noticed that it did not match and that it was loose.The nail is removed a little to check its connection and found to be broken in its proximal part, which did not provide stability.It was decided to change the nail for one of the same size, but of a different diameter.There was a surgical delay of approximately two (2) hours and thirty (30) minutes.A left implant 7x 270 was placed and distal and proximal locks were made.This report involves one (1) 8.5mm ti multiloc humeral nail left/cann/270mm-sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Product code: (b)(4).Lot # 72p7479.Manufacturing site: (b)(4).Release to warehouse date: january 8, 2021 expiration date: december 1, 2025 a manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the received photo.Visual analysis of the photo revealed that the proximal end of the multiloc hn ø8.5 le cann l270 has broken.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for multiloc hn ø8.5 le cann l270.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.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.Investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that multiloc hn ø8.5 le cann l270 was observed with damaged, partially breakage at the top part, near of the threaded tip.A dimensional inspection was performed for the multiloc hn ø8.5 le cann l270 was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the multiloc hn ø8.5 le cann l270 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: a manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified., a manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified.

• Brand Name: 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/270MM-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13757284
• Report Number: 8030965-2022-01576
• Device Sequence Number: 2369561
• Product Code: HSB
• UDI-Device Identifier: 10886982090102
• UDI-Public: (01)10886982090102
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K120807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2025
• Device Model Number: 04.019.270S
• Device Catalogue Number: 04.019.270S
• Device Lot Number: 72P7479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING.
• Patient Sex: Unknown