Alleged failure: when use of stryker femoral 6 mm aimer guide under knee arthroscopy operation, loose debri in the joint was seen coming from the guide - not from the k-wire.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) use of excessive force, 2) improper reprocessing cycles/agents used, 3) instrument not dried properly after reprocessing, 4) improper storage conditions.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
|