MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH INSERT-HANDLE F/ETN RADIOLUC SHORT; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.010.013

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the connection screw for the aiming arm was too short and the thread on the aiming arm is stripped.The surgery was completed successfully with another aiming arm and there was no surgical delay reported.This report is for one (1) insert-handle f/etn radioluc short.This is report 2 of 3 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- the received aiming arm and insertion handle were received in a used condition.No significant damages could be detected, besides of some scratches.The complaint condition that the connection screw of the aiming arm is too short (more then 5mm) can be confirmed.Nevertheless, we assume that the connecting screw was mistakenly exchanged with another connecting screw during the cleaning process or use.The aiming arm underwent a 100% functional check before leaving the plant.Furthermore, the instrument is now over 8 years in use, and we assume that such an obvious failure would be detected already at first use.Based on the measurements, we rather assume that the screw belongs to the aiming arm 03.010.018, which is also use with the expert tibia nail set.The insertion handle show no defect and the complaint condition is only related to the short connection screw of the aiming arm.Consequently, we conclude that the cause of failure is not due to any manufacturing non-conformances.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed device history lot part: 03.010.013, lot: l763293, manufacturing site: hägendorf, release to warehouse date: 17 jan 2019.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: INSERT-HANDLE F/ETN RADIOLUC SHORT
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10817860
• MDR Text Key: 219376280
• Report Number: 8030965-2020-08821
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.013
• Device Lot Number: L763293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1