MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVING CAP/THREADED; MISC, SURGICAL, ORTHO, INSTRUMENT

Model Number 03.010.523

Device Problems Device Handling Problem (3265); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device received.A review of the device history record.Device history lot: part: 03.010.523, lot: 8836145, manufacturing site: bettlach, release to warehouse date: 09.May.2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Investigation summary background: it was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the radiolucent insertion handle for expert nail and driving cap/threaded were stuck together.There was no patient or hospital involvement.This complaint involves two (2) devices.Investigation flow: damage / device interaction / functional.Visual inspection: the driving cap/threaded (part # 03.010.523 lot # 8836145) was received at us cq.The threaded distal tip broken off at the most proximal thread form.The broken off distal threaded tip of the device was received lodged within another device, insertion handle investigated.The device had surface scratches along the shaft and several dents on the top of the proximal head from hammer blows.These cosmetic issues are consistent with normal wear.No other issues were identified with the device.The received condition is consistent with the complaint condition thus the complaint is confirmed.Functional test: a functional test could not be performed as the threaded tip was stuck inside the radiolucent insertion handle for expert nails/100mm (p/n 03.010.486 l/n 8474746).The allegation of inability to disassemble cannot be replicated at us cq.Dimensional inspection: due to the break being slightly oblique in nature and it only leaving the most proximal thread, it was not possible to obtain an accurate measurement of the minor/major diameter of the threaded tip.The diameter of the grove just proximal to the broken tip as well as the shaft diameter was measured instead.Conclusion: the measuring result does show conformity.Document/specification review: the following drawing, reflecting the manufactured and current revision, was reviewed.Connector for insertion handle se_380067 rev j-l.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Manufacturing record evaluation: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Conclusion: the complaint condition is confirmed for the driving cap/threaded (part # 03.010.523 lot # 8836145) as the threaded distal tip was broken off at the most proximal thread form.While no definitive root cause could be determined, it is possible the device encountered unintended forces during use (off-axis or excessive hammer blows based on the numerous dents on the proximal surface).There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings pie-1565883 has been launched to address the identified issue.The need for further corrective/preventive action will be assessed within the pie.Further investigation will not be conducted in this complaint as it will be addressed.Sustaining engineering ticket also opened to address this issue.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 on an unknown date, during routine incoming inspection of a loaner set, it was observed that the radiolucent insertion handle for expert nail and driving cap/threaded were stuck together.There was no patient or hospital involvement.This complaint involves two (2) devices.This report is for one (1) driving cap/threaded.This report is 2 of 2 for (b)(4).

• Brand Name: DRIVING CAP/THREADED
• Type of Device: MISC, SURGICAL, ORTHO, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9549139
• MDR Text Key: 190479402
• Report Number: 2939274-2020-00045
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982069351
• UDI-Public: (01)10886982069351
• Combination Product (y/n): N
• 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
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.523
• Device Catalogue Number: 03.010.523
• Device Lot Number: 8836145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1