MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SPEEDLOCK SLEEVE GAMMA3 180; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-1118
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "doing case and noticed targeting arm was cracked and speed sleeve did not target distal screw properly.The drill bit went posterior.The nail was already seated so we just used a different speed sleeve.".
Additional Manufacturer Narrative
The alleged event was not confirmed.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).Although distributed in 2011 the item showed the typical signs of use but was fully functional.Alleged improper accuracy in targeting could not be reproduce.In case of any deviation it is realized prior to use.Preoperative testing is required in the labelling; maintaining measures during and after re-processing is also highlighted in the labelling.Although a root cause could not be determined the alleged event was classified having been caused by a suboptimal intra-operative procedure and was regarded being user related.In case other essential information becomes available were reserve the right to re-reopen the case for investigation and to assess a new root cause.
Event or Problem Description
As reported: "doing case and noticed targeting arm was cracked and speed sleeve did not target distal screw properly.The drill bit went posterior.The nail was already seated so we just used a different speed sleeve.".

• Brand Name: SPEEDLOCK SLEEVE GAMMA3 180
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10952141
• Report Number: 0009610622-2020-00829
• Device Sequence Number: 3217386
• Product Code: LXH
• UDI-Device Identifier: 07613154893652
• UDI-Public: 07613154893652
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 1320-1118
• Device Catalogue Number: 13201118
• Device Lot Number: KP309437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1