MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW GAMMA3 8X35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0090
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2020
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
Customer reported to sales rep that: "we have a nail gamma stuck on the nail holder." sales rep reported that: "yesterday [surgeon] placed a short gamma nail on a patient, and when he wanted to remove the nail holder from the nail, he couldn't unscrew it.He opened another ancillary to put another nail in.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.During simulation of pre-op check the three returned devices could be assembled and disassembled without excessive force as intended.The subject of the reported event could not be reproduced.Signs of seizing / fretting corrosion were not found on the items.The threads of nhs and nail are in good condition.The device inspection revealed the following: visual inspection: we received the items in assembled condition.The nail holding screw [nhs] could be loosened with the corresponding ball-tipped screwdriver.Functional inspection: simulation of pre-operative function test performed on the returned devices revealed that function is given in full.The returned devices [nail, nhs and target device] could be assembled and disassembled as intended.Dimensional inspection: correct dimensions were confirmed by above mentioned successful functional check.Referring to the subject of the complaint it cannot be excluded that the nhs had been screwed in the nail with excessive force.Possibly, in this case the torsional force had not been applied constantly to the nhs but with a quick movement which would explain the relatively high loosening torque whilst disassembling the items and thus, rather classified as user related.However, the case was not reproducible and based on investigation an exact root cause could not be determined.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.
Event or Problem Description
Customer reported to sales rep that: "we have a nail gamma stuck on the nail holder." sales rep reported that: "yesterday [surgeon] placed a short gamma nail on a patient, and when he wanted to remove the nail holder from the nail, he couldn't unscrew it.He opened another ancillary to put another nail in.".

• Brand Name: NAIL HOLDING SCREW GAMMA3 8X35MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 10033570
• Report Number: 0009610622-2020-00187
• Device Sequence Number: 2614450
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: 1320-0090
• Device Catalogue Number: 13200090
• Device Lot Number: KSS163347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1