MAUDE Adverse Event Report: SYNTHES GMBH RETENT PIN SCRDRIVER QC HEX 12/SHT/XL25; SCREWDRIVER

Catalog Number 03.045.008

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, sales representative received a package.The pack slip is a mess, looks like mice were eating it.The item included retention pin for screwdriver, was only the package, which was badly damaged and the item wasn¿t even in the package.It was empty.Only the packaging shipped.Sales rep going to need this piece to ship.It is for a new tibial nail set (ans).Concomitant device reported: unk - kits/sets (part# unknown; lot# unknown; quantity: unknown) this report is for one (1) retention pin for screwdriver w/ q c -hex 12mm/short/xl25 this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.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.

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.The photos were returned to depuy synthes and sent to manufacturing site: jabil hägendorf for evaluation.The jabil hägendorf team conducted a visual inspection of the returned photo evidence visual analysis of the photo was performed on the retent pin scrdriver qc hex 12/sht/xl25.As the part was not returned and only two pictures were provided during a visual inspection and review was performed.This review of the photos identified the tip cover 60129715, however the part 03.045.008 cannot be identified.Further, based on the provided pictures, no interruption of the sealing seems to be present.However, the complete package is not shown in the pictures (bottom side end in picture is not visible), which prevents a review of the whole packaging.The visual inspection of the pictures provided confirmed damage to the packaging of the part 03.045.008.No further investigation of the part or its packaging could be performed as the part was never returned to the process engineering department at the manufacturing site hägendorf for the manufacturing investigation.All documents related to the manufacture and packaging of part 03.045.008, lot 5035p58 were reviewed and no deviations were identified, confirming that the part was manufactured in accordance with all the valid procedures and documents at that time.While no root cause can be established for the observed condition, it is possible that the packaging got damaged during shipping/transport process.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 retent pin scrdriver qc hex 12/sht/xl25.There is no indication that a design or manufacturing issue has caused the complaint condition.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.H4,h6 part number: 03.045.008, lot number: 5035p58, manufacturing site: haegendorf, release to warehouse date: 25.04.2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: RETENT PIN SCRDRIVER QC HEX 12/SHT/XL25
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17433325
• MDR Text Key: 320156719
• Report Number: 8030965-2023-09586
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07612334167859
• UDI-Public: (01)07612334167859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.045.008
• Device Lot Number: 5035P58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - KITS/SETS