MAUDE Adverse Event Report: STRYKER GMBH HEXAPOD STRUT, LONG HOFFMANN LRF 183MM-295MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49350040
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/02/2018
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
It was reported that upon scheduled removal of the external fixation construct on patient's ankle (side not reported), a large strut was observed to be broken apart.Three 2.0 wires were also reported broken at the junction of the bolt adaptors.Previous followup visits by the patient showed the entire construct intact.
Additional Manufacturer Narrative
The reported event that hexapod strut, long hoffmann lrf 183mm-295mm was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be manufacturing and supplier related.The failure was caused by manufacturing components out of specifications.The event involved a product problem indicating a non-conformity which is investigated and addressed through a nc and a capa.No further action is required at this time.Product surveillance will continue to monitor complaints of this type for adverse trends.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that upon scheduled removal of the external fixation construct on patient's ankle (side not reported), a large strut was observed to be broken apart.Three 2.0 wires were also reported broken at the junction of the bolt adaptors.Previous followup visits by the patient showed the entire construct intact.
Additional Manufacturer Narrative
The reported event that hexapod strut, long hoffmann lrf 183mm-295mm was alleged of 'implant breakage after surgery' could be confirmed.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.The device inspection revealed the failure mode is confirmed: the device is broken and not functional anymore.A 4mm pin has broken off and is missing from the assembly.Unfortunately, this broken pin was not returned and is not available for inspection, thus we cannot determine the root cause of this breakage.In addition, the device was removed at the end of the treatment and the correction was successful; no adverse consequence was reported.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that upon scheduled removal of the external fixation construct on patient's ankle (side not reported), a large strut was observed to be broken apart.Three 2.0 wires were also reported broken at the junction of the bolt adaptors.Previous followup visits by the patient showed the entire construct intact.

• Brand Name: HEXAPOD STRUT, LONG HOFFMANN LRF 183MM-295MM
• 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: 7551198
• Report Number: 0008031020-2018-00407
• Device Sequence Number: 10799132
• Product Code: KTT
• UDI-Device Identifier: 07613327294200
• UDI-Public: 07613327294200
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2018

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: Lay User/Patient
• Device Catalogue Number: 49350040
• Device Lot Number: Y08556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 08/30/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 08/08/2018; 09/17/2018
• 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: Other
• Patient Age: 50 YR