MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION(TM) ADM REDU TOOL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1235-0-020

Device Problems Break (1069); Fracture (1260); Device Damaged by Another Device (2915); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The instrument broke when hit with a mallet.

Manufacturer Narrative

Correction: correct product code and common device name.An event regarding crack/fracture involving an adm reduction tool was reported.The event was confirmed.Method & results: -device evaluation and results: "based on macroscopic features on the fracture surface, the examination showed that the silicone tip broke from an overload condition.The fracture initiating at the outward surface and propagating to the metal tip of the tool.Damage was also observed at another location of the silicone tip." a material analysis was performed and concluded: "the silicone tip fractured from an overload condition with the fracture initiating from the outer surface of the silicone tip towards the metal tip of the tool.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: not performed as medical records were not received for evaluation and no adverse consequences to the patient were reported.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a material analysis was performed and concluded that "no material or manufacturing defects were observed on the surfaces examined." no further investigation is required at this time.If further relevant information becomes available this investigation will be re-opened.

Event Description

The instrument broke when hit with a mallet.

• Brand Name: RESTORATION(TM) ADM REDU TOOL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: suzanne neuschwanter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6329615
• MDR Text Key: 67652971
• Report Number: 0002249697-2017-00557
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 1235-0-020
• Device Lot Number: G5489546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other