MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION SLEEVE HANDLE; INSTRUMENT COMPRESSION

Model Number	03.226.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, it was notified that the compression sleeve handle no longer connects properly to the 2.4- or 3.0-mm compression sleeves.It does not slide into the proper recess to ¿lock¿ into place and is therefore loose.There was no patient consequence.Concomitant device reported: unk - screws: 2.4/3.0mm headless compression (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device.This report is for (1) compression sleeve handle.This report is 1 of 1 for (b)(4).

• Brand Name: COMPRESSION SLEEVE HANDLE
• 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: 12572699
• Report Number: 2939274-2021-05904
• Device Sequence Number: 19754589
• Product Code: HWN
• UDI-Device Identifier: 10886982077066
• UDI-Public: (01)10886982077066
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: 03.226.006
• Device Catalogue Number: 03.226.006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1