MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING

Catalog Number	313.992
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Date of event: unknown.Device is an instrument and is not implanted/explanted.Device history records review not available for reporting at this time.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during routine inspection, it was found that the tip of screwdriver shaft was broke and was missing a blade.The missing piece was less than 2 mm.It was also reported that the missing piece of the screwdriver was not accounted for and could not be located.It was unknown as to how the device broke.There is no patient involvement.There is no additional information provided.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional 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.Part 313.992, lot 3409274: manufacturing site: haegendorf.Release to warehouse date: march 30, 2010.No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: the returned screwdriver was inspected and the complaint was confirmed.Visual inspection performed at customer quality observed that the tip of the screwdriver shaft was broken.Broken fragments were not returned at the customer quality.No new issues were identified on the remaining portions of the returned device.The received condition agree with the complaint description and the complaint was confirmed.Relevant drawings for the returned device were reviewed.Dimensional analysis could not be performed on the relevant features due to the post manufacture damage.No root cause could be determined.A device history review was performed for the returned instrument¿s lot number and no non-conformance reports (ncrs), material review reports (mrrs) or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Also, based on the device history record review, there is no indication that any issues with material or material properties contributed to the complaint condition.While no definitive root cause could be determined it is possible that any unintended forces encountered by the device such as being dropped off during usage or handling could have contributed to complaint condition.During the investigation, no product design or 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.Corrected data: date of report/date rec¿d by mfr: initially reported as april 03, 2018; should be april 02, 2018.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: 1.3MM CRUCIFORM SCREWDRIVER SHAFT, SELF-RETAINING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7445032
• Report Number: 2939274-2018-51832
• Device Sequence Number: 13717198
• Product Code: HXX
• UDI-Device Identifier: 10886982188342
• UDI-Public: (01)10886982188342
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 313.992
• Device Lot Number: 3409274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1