MAUDE Adverse Event Report: SYNTHES GMBH LOCKING SCREW FOR IM NAIL Ø 5MM/ 44MM/ XL25/ STERILE; SCREW, FIXATION, BONE

Catalog Number	04.045.044S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from australia reports an event as follows: it was reported that on (b)(6) 2023, a broken tna needed removing and re-nailing.The nail had broken at the distal end.The nail was originally implanted on (b)(6) 2023, and was removed on (b)(6) 2023 and re-nailed with a 10x360mm tna.All previous nail items were removed.The revision procedure was performed because of the broken implant, the fracture had not healed.The patient had significant distal bone loss and a masquelet procedure was completed.The patient had borne weight after bone graft had been inserted, and this is when the nail broke.Reamings sent off during the case came back positive for infection.The revision procedure was completed successfully and the patient is progressing well.No further information is available.This report is for a locking screw for im nail ø 5mm/ 44mm/ xl25/ sterile.This is report 5 of 7 for (b)(4).
Additional 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: d2: additional procodes: hsb, jds.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is (b)(6) 2023.E3: initial reporter is a synthes employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Additional 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: 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 there were no product problems observed with lockscr f/nails ø5 l44 xl25.There was no evidence that suggested that the reported adverse event was due to a device non-conformance.The investigation was not able to confirm the reported event.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 not confirmed for lockscr f/nails ø5 l44 xl25.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 review (dhr): a manufacturing record evaluation was performed for the finished device product code : 04.045.044s, lot number : 426p187.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 21/10/2021, manufacturing site: jabil grenchen, expiry date: 01/10/2031.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: LOCKING SCREW FOR IM NAIL Ø 5MM/ 44MM/ XL25/ STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN; solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17975196
• Report Number: 8030965-2023-13214
• Device Sequence Number: 14344706
• Product Code: HWC
• UDI-Device Identifier: 10886982294449
• UDI-Public: (01)10886982294449
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.045.044S
• Device Lot Number: 426P187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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: DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QC F; DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QC F; LOCKSCR F/NAILS Ø5 L36 XL25; LOCKSCR F/NAILS Ø5 L40 XL25; LOCKSCR F/NAILS Ø5 L42 XL25; LOCKSCR F/NAILS Ø5 L46 XL25; LOCKSCR F/NAILS Ø5 L46 XL25; TIBIAL NAIL ADVANCED Ø9 L360; TIBIAL NAIL ADVANCED Ø9 L375; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male