MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM T2 PROX. HUM.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-2035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
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: during t2ph surgery for proximal humerus (left), crack of the distal end of the target device was noticed.It is unknown whether the device was cracked because it interfered with nail during drilling of the nail of the most distal.It was planning to insert two distal screws, but the surgeon inserted only one and completed the operation.
Additional Manufacturer Narrative
The reported event could be confirmed, since physical inspection revealed a crack.The originally white printings of the inscription had changed to fawn; an indication for a high level of sterilization cycles.A crack was found in the cfr material at the distal portion of the jig.Further visible damage was not found.Although cracked ¿ simulation of a pre-functional check of the target device returned revealed that the sleeve could be assembled as intended and function was sufficiently given.No deviations were found during review of the manufacturing and inspection documents (dhr).A review of the dhr revealed no discrepancies in material or manufacturing.A check of the function on 100% of the devices [sub-supplier] and additional in-house spot check of the lot in question revealed function was given in full on the devices at the stage of delivery.The general appearance of the device indicates a high number of uses.Cracking of the clip could be reproduced with bending the drill sleeve under significant angulations while the sleeve had not been inserted as intended completely into clip and target device [tested with sample items].Referring to the very long period since manufacturing [manufactured in 2011] the device has reached the end of its useful service-life and had fulfilled its tasks in former surgeries as intended, until the reported event, without problems reported.The case is attributed to a long-term usage combined with a misuse.
Event or Problem Description
As reported: during t2ph surgery for proximal humerus (left), crack of the distal end of the target device was noticed.It is unknown whether the device was cracked because it interfered with nail during drilling of the nail of the most distal.It was planning to insert two distal screws, but the surgeon inserted only one and completed the operation.

• Brand Name: TARGETING ARM T2 PROX. HUM.
• 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: 11215931
• Report Number: 0009610622-2021-00244
• Device Sequence Number: 3571438
• Product Code: LXH
• UDI-Device Identifier: 04546540379658
• UDI-Public: 04546540379658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 1806-2035
• Device Catalogue Number: 18062035
• Device Lot Number: KHI 113175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1