MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LARGE HANDLE WITH QUICK COUPLING; TAP,BONE

Catalog Number 311.431

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The device has been 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent a surgery.Before the sterilization, when the hospital checked the devices, the person in charge had difficulty in attaching and detaching a screwdriver shaft from the handle because the handle¿s connection part was stuck.The surgeon used another device in the surgery, and the surgery was completed successfully without any surgical delay.Patient outcome is reported as stable.No further information is available.Concomitant device reported: screwdriver (part # unknown, lot # unknown, quantity 1).This report is for one (1) large handle with quick coupling.This is report 1 of 2 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, h6: a product investigation was conducted: investigation site: cq zuchwil, selected flow: device interaction / functional.Visual investigation: the returned handle with quick coupling is in very used condition and shows wear marks and scratches on the surface of the whole instrument.The coupling is stiff and therefore not easy to use.The coupling is still able to hold the instrument in place but based on the fact that the instrument is old and in used condition a proper handling is not given anymore.Investigation conclusion: the complaint is confirmed as the sleeve of handle which hold the torque limiter is stiff running.The device is 6 years old and in a very used condition, this let us exclude a manufacturing related issue.Per guidance provided in windchill document, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.End of life definition per important information leaflet, limits on reprocessing: end of life of a device is normally determined by wear and damage due to use.Evidence of damage and wear on a device may include but is not limited to corrosion (i.E.Rust, pitting), discoloration, excessive scratches, flaking, wear and cracks.Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.No manufacturing related issue was identified and/or confirmed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.Device history lot part: 311.431, lot: 9167721, manufacturing site: bettlach, release to warehouse date: december 10, 2014.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: LARGE HANDLE WITH QUICK COUPLING
• Type of Device: TAP,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10568193
• MDR Text Key: 207980815
• Report Number: 8030965-2020-07314
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819259836
• UDI-Public: (01)07611819259836
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.431
• Device Lot Number: 9167721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: SHAFTS; UNK - SCREWDRIVERS: SHAFTS