MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SCREWDRIVER RATCHETING HANDLE, MANDIBULAR RECONSTRUCTION SYSTEM, 11.5CM; INSTRUMENT

Catalog Number 62-20290

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation shows that the product subject to the complaint had reached its life time at the event date of the reported incident.The relevant quality documents indicate that the product was manufactured according to specifications and was accepted into stock without any discrepancies.There is no indication for a quality issue with the article in question, nor is there any indication for a deviation from the defined quality specifications within development or manufacturing.No indications for unusual or unexpected circumstances could be identified, either.Moreover it is to be concluded that the reported incident originated from a common case of wear and tear resulting from aging as it is to be expected with mechanical medical devices subject to reprocessing after reaching their life time, not making any further action necessary.This complaint will be considered in statistical analyses at frequent intervals.

Event Description

Initially it was reported by the company representative that the screwdriver handle could not longer perform its ratcheting function.When the device was received by the manufacturer for evaluation, although investigators were unable to re-create the reported malfunction, it was noted that a piece of the plastic grip had broken off.

Manufacturer Narrative

The investigation shows that the product subject to the complaint had reached its life time at the event date of the reported incident.The relevant quality documents indicate that the product was manufactured according to specifications and was accepted into stock without any discrepancies.There is no indication for a quality issue with the article in question, nor is there any indication for a deviation from the defined quality specifications within development or manufacturing.No indications for unusual or unexpected circumstances could be identified, either.Moreover it is to be concluded that the reported incident originated from a common case of wear and tear resulting from aging as it is to be expected with mechanical medical devices subject to reprocessing after reaching their life time, not making any further action necessary.This complaint will be considered in statistical analyses at frequent intervals.

Event Description

Initially it was reported by the company representative that the screwdriver handle could not longer perform its ratcheting function.When the device was received by the manufacturer for evaluation, although investigators were unable to re-create the reported malfunction, it was noted that a piece of the plastic grip had broken off.

• Brand Name: SCREWDRIVER RATCHETING HANDLE, MANDIBULAR RECONSTRUCTION SYSTEM, 11.5CM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 7645717
• MDR Text Key: 112895124
• Report Number: 0008010177-2018-00057
• Device Sequence Number: 0
• Product Code: LXH
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 62-20290
• Device Lot Number: U11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1