MAUDE Adverse Event Report: STRYKER GMBH TISSUE PROTECTION SLEEVE, LONG IMN INSTRUMENTS Ø9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23510070
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "after drilling, the guide was found to be damaged.".
Event or Problem Description
As reported: "after drilling, the guide was found to be damaged.".
Additional Manufacturer Narrative
Please note correction to d4 / lot code kp431181.The reported event could be confirmed, since the device was returned with a broken plastic handle / adapter.Visual inspection: the tissue protection sleeve, long imn instruments ø9mm was returned with a cracked plastic handle.This plastic handle also presents the counterpart for the locking drill sleeve [locking mechanism of the whole sleeve assembly].The crack had completely divided the plastic part.Signs of damage at that area, like imprints from hitting or other kinds of mishandling were not apparent.The remaining plastic appearance was in good condition.No other deficiencies determined.Functional inspection: function was no longer given as intended.Dimensional inspection: manufacturing and inspection records confirmed the item had been released in accordance to specs.Mechanical signs of damage were not found.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.It was reported that the event was noticed ¿during surgery¿ occurred ¿after drilling¿¿.With given available information, the root cause could not be determined since the kind and the level of applied forces remained unknown.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: TISSUE PROTECTION SLEEVE, LONG IMN INSTRUMENTS Ø9MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18037294
• Report Number: 0009610622-2023-00381
• Device Sequence Number: 7344982
• Product Code: LXH
• UDI-Device Identifier: 07613327368154
• UDI-Public: 07613327368154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

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: 23510070
• Device Lot Number: KP431181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown