MAUDE Adverse Event Report: AESCULAP AG SUSI WEITLANER RETRACTOR 3X4T.SEMI-SHARP; GENERAL SURGICAL INSTRUMENTS

Model Number BV067SU

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)

Patient Problems No Code Available (3191); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.Initial reporter - the adverse event was reported by the distributor.The end customer is not disclosed by the dealer and must remain open.

Event Description

It was reported that there was an issue with a single use weitlaner retractor.According to the complaint description the ratchet broke into 2 pieces during use.A plastic piece was falling into the axilla of the patient and could be retrieved.An additional medical intervention (washing of the wound) was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the device was provided for investigation in a decontaminated condition.The ratchet of the retractor is broken, two fragments were provided by customer.Investigation was carried out visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to an overload situation.No pores, inclusions or foreign bodies could be found on the point of fracture.The device quality and manufacturing history records (dhr) will be checked for the lot number by the production plant.The review is still pending.If the review shows any conspicuities, the report will be updated and actions will be initiated.There are no similar complaints against the same lot number with this error pattern.The root cause of the mentioned malfunction is most probably usage related.Based on the investigations and results of the 8d report no capa is necessary.

• Brand Name: SUSI WEITLANER RETRACTOR 3X4T.SEMI-SHARP
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10515509
• MDR Text Key: 206372962
• Report Number: 9610612-2020-00480
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: BV067SU
• Device Catalogue Number: BV067SU
• Device Lot Number: 4507664901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention