MAUDE Adverse Event Report: SYNTHES GMBH 7MM TI CANNULATED HUMERAL NAIL-EX/240MM-STERILE; NAIL, FIXATION, BONE

Catalog Number 04.001.228S

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unknown nails: expert humeral/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 synthes reports an event in (b)(6) as follows: it was reported that on unknown date, the patient experienced a broken expert humerus nail which needs to be revised.The patient received the implant in 2020.This report involves one (1) unknown nails: expert humeral.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.H3, h4, h6: part # 04.001.228s, lot # 6l96727.Manufacturing site: werk selzach logistik.Release to warehouse date: may 25, 2020.A manufacturing record evaluation was performed for the finished article lot 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 returned photo.Visual analysis of the photo revealed that the expert hn ø7 cann l240 tan appears to be broken across the superior distal locking screw insertion hole.A mid shaft fracture is visible at the left humerus with signs of hypertrophic union.Additionally, a second fracture of the bone is visible at the same section of the nail breakage.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 the expert hn ø7 cann l240 tan.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.

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: b7, d6a, d6b, d9, d10, g1.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Additionally, a visual inspection of the returned device was performed from attachment (source x-ray).Visual analysis of the returned sample revealed that the expert hn ø7 cann l240 tan appears to be broken across the superior distal locking screw insertion hole, only the distal fragment of the nail was returned.X-ray evidence was reviewed, a mid shaft fracture is visible at the left humerus with signs of hypertrophic union.Additionally, a second fracture of the bone is visible at the same section of the nail breakage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the expert hn ø7 cann l240 tan.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.

• Brand Name: 7MM TI CANNULATED HUMERAL NAIL-EX/240MM-STERILE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14268954
• MDR Text Key: 290574519
• Report Number: 8030965-2022-02854
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819782822
• UDI-Public: (01)07611819782822
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.001.228S
• Device Lot Number: 6L96727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; LOCKSCR Ø4 L36 F/NAILS TAN DBLUE; SPIRAL BLADE F/UHN+PHN L40 TAN; UNK - NAIL HEAD ELEMENTS: HELICAL BLADE; UNK - SCREWS: LOCKING: EXPERT HUMERAL NAIL; UNK - SCREWS: LOCKING: EXPERT HUMERAL NAIL
• Patient Outcome(s): Required Intervention