MAUDE Adverse Event Report: STRYKER GMBH CONNECTING NUT - SHORT HOFFMANN LRF M8 X 6MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	4933-1-010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
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: "the patient was walking with the hoffmann lrf / hexapod frame on and the clamp broke".Rep reported that the clamp was replaced.
Event or Problem Description
As reported: "the patient was walking with the hoffmann lrf / hexapod frame on and the clamp broke".Rep reported that the clamp was replaced.
Additional Manufacturer Narrative
The reported event that hoffmann lrf apex pin adaptor was alleged of 'implant breakage after surgery" could be confirmed.The root cause of this breakage has been identified as a design issue (material not resistant enough to corrosion).This problem has been identified during nc and is addressed by capa.A new material will be implemented.As this breakage is due to a design issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Indications for any material, manufacturing or design related problems were not determined in the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "the patient was walking with the hoffmann lrf / hexapod frame on and the clamp broke".Rep reported that the clamp was replaced.
Additional Manufacturer Narrative
Corrections to concomitant medical products/device evaluated by mfr.The reported event that connecting nut - short hoffmann lrf m8 x 6mm was alleged of 'implant breakage after surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on provided information, the most likely root cause is attributed to be patient related.It was reported to be a young highly active patient and the breakage occurred 1 month after implantation.Please note that the instruction for use (v15034 rev aa external fixation devices ifu) reads: ''adverses effects: in many instances, adverse results may be clinically related rather than device related.1.These devices can break when subjected to the increased loading associated with delayed unions and/or non unions.External fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed, or does not occur, the appliance may eventually break due to fatigue.Loads on the device produced by load bearing, and the patient¿s activity level, will dictate the longevity of the appliance." [original statements].A review of the device history was not possible because the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CONNECTING NUT - SHORT HOFFMANN LRF M8 X 6MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7472342
• Report Number: 0008031020-2018-00328
• Device Sequence Number: 1642826
• Product Code: KTT
• UDI-Device Identifier: 07613252610304
• UDI-Public: (01)07613252610304
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113327
• 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,Followup
• Report Date (Section B): 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 4933-1-010
• Device Catalogue Number: 49331010
• Device Lot Number: Z12644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 03/29/2019
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 07/27/2018; 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR