MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5MM K-WIRE; INSTRUMENT COMPRESSION

Model Number	03.111.023
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The compression/distraction holding sleeve/2.5 mm k-wire (p/n 03.111.023 lot unk) was received showing the three most proximal thread forms stripped.The shaft is also significantly scratched at the area of interface with a compression/distraction device (intended mating instrument).Due to the scratches, the lot number etch is illegible.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition is confirmed for the compression/distraction holding sleeve/2.5 mm k-wire (p/n 03.111.023 lot unk) as the three most proximal thread forms were stripped.The shaft is also significantly scratched at the area of interface with a compression/distraction device (intended mating instrument).Due to the scratches, the lot number etch is illegible.While no definitive root cause could be determined, it is likely that the condition of the device was due to normal wear from consistent use and reprocessing over its lifetime (2+ years).During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 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 or Problem Description
It was reported on (b)(6) 2019, during an inventory of the foot instrument set, it was noticed that one of the compression or distraction holding sleeves, the thread are stripping and is not working correctly.There was no patient involvement.This report is for one (1) compression/distraction holding sleeve/2.5 mm k-wire.This is report 1 of 1 for (b)(4).

• Brand Name: COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5MM K-WIRE
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8893087
• Report Number: 2939274-2019-59817
• Device Sequence Number: 16203397
• Product Code: HWN
• UDI-Device Identifier: 10886982072221
• UDI-Public: (01)10886982072221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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 Model Number: 03.111.023
• Device Catalogue Number: 03.111.023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1