MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE FOR 90° SCREWDRIVER; DRILL, BONE, POWERED

Model Number 03.505.004

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional procodes: dzj, hxx.Part: 03.505.004; lot: 8062713; manufacturing site: (b)(4), supplier: (b)(4); release to warehouse date: november 27, 2006 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: visual inspections revealed that the distal alignment tab and distal tip threads were found stripped / worn.The reported condition for bent is not confirmed.The mating part was not returned to replicate the reported condition of loose/ would not hold.Hence, we cannot confirm the loose complaint.Functional test: it was not performed as the mating part was not returned for the investigation.Document/ specification review: the following document was reviewed.Handle for 90° screwdriver dimensional inspection: dimensional inspection was not performed due to manufacturing damages / stripped threads.Device history record (dhr) review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Conclusion: the reported conditions are not confirmed.Regarding distal alignment tab and distal tip threads, - a definitive root cause could not be determined.It is possible that rough handling during use and/or processing could have contributed to the stripping of the threads and tab.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to 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.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

It was reported that after thoracic surgery on (b)(6) 2019, when reassembling the 90-degree drill, the sales consultant noticed that the nut holding the handpiece was stripped and would not hold together.There was no patient consequence.This report is for a handle for 90° screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: HANDLE FOR 90° SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8470749
• MDR Text Key: 140613124
• Report Number: 2939274-2019-57206
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587013305
• UDI-Public: (01)10887587013305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.505.004
• Device Catalogue Number: 03.505.004
• Device Lot Number: 8062713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2006
• 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