MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN RASP; INSTRUMENT

Catalog Number UNK_SEL

Device Problems Material Discolored (1170); Product Quality Problem (1506); Component Missing (2306); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

The hospital reported the following event : dr.(b)(6) requested a silicone ppi for his upcoming case.When the sterilization was completed, it was found that the equipment was not usable (blackened sleeves) and that an implant ghost was missing (a lost second was found yesterday)'.The block therefore requested a second emergency lending instrument to ensure the intervention.The responsible pharmacist informed me that according to traceability, the instrument set had not been used since 2015.We therefore have an unusable and incomplete silicone ipp instrument set.Surgical delay: one day.New information received from the sales rep on january 30th 2019 : "ipp silicone instrument set on loan.After 3 washes traces of wear: rasp handles whose paint remains on the fingers.".

Manufacturer Narrative

The reported event could be confirmed only based on the pictures sent, since the devices weren't returned for evaluation.Based on investigation, the root cause was attributed to be user related.The failure was caused by incorrect cleaning.The customer mentioned that the devices were cleaned using an alkaline detergents, which clearly is against the indications of the cleaning and sterilization guide.Indeed, this guide clearly mentions that "[¿] for cleaning and/or disinfection of medical devices manufactured from aluminium alloys a ph neutral agent should be used*.Contact with strong alkaline detergents or solutions containing iodine or chlorine should be avoided, since the aluminium can be chemically attacked and the instrument may be damaged.¿[¿] * in case of aluminium instruments neutral/enzymatic detergents are recommended (for example neodisher medizym).¿ this event can thus clearly be classified as user misuse of the product.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 Description

The hospital reported the following event : "dr.(b)(6).Requested a silicone ppi for his upcoming case.When the sterilization was completed, it was found that the equipment was not usable (blackened sleeves) and that an implant ghost was missing (a lost second was found yesterday)'.The block therefore requested a second emergency lending instrument to ensure the intervention.The responsible pharmacist informed me that according to traceability, the instrument set had not been used since 2015.We therefore have an unusable and incomplete silicone ipp instrument set.Surgical delay : one day new information received from the sales rep on (b)(6)2019: "ipp silicone instrument set on loan.After 3 washes traces of wear: rasp handles whose paint remains on the fingers.".

• Brand Name: UNKNOWN RASP
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8359163
• MDR Text Key: 137429945
• Report Number: 0008031020-2019-00086
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other